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Characterising Arm Recovery in People With Severe Stroke (CARPSS)

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ClinicalTrials.gov Identifier: NCT02464085
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
The main goal of this program of research is to advance our understanding of how the severely damaged brain changes over the first 12-months post stroke. The investigators will determine 'who recovers', 'who does not recover', and 'why'

Condition or disease Intervention/treatment
Stroke Other: Longitudinal evaluation of recovery

Detailed Description:
The main goal of this program of research is to advance our understanding of how the severely damaged brain changes over the first 12-months post stroke. The prevalence and severity of stroke related arm disability is increasing and the prospect of optimal recovery is poor. Studies have demonstrated that stroke survivors with severe disability lack early indicators (<7-days to <1-month post-stroke) of a good prognosis, such as active movement at the shoulder and wrist and integrity of the corticospinal tract. This has propagated the clinical belief that this cohort are unlikely to functionally benefit from rehabilitation efforts. However, it is possible that indicators of potential for recovery - either neuroanatomical or clinical - may present in individuals with severe stroke later, that is beyond the early time-period. Indeed, there is increasing evidence of the potential for ongoing improvements in motor performance in response to intensive interventions that are undertaken 6-months or more post-stroke. This therefore, implies that there is some degree of untapped recovery potential. However, as very few studies have longitudinally explored the potential indicators of recovery in a severe cohort, the dynamic capacity of the severely damaged remains unknown. Thus, there is a need to determine 'who recovers', 'who does not recover', and 'why' to be able to promote optimal arm recovery in people with severe impairment after stroke. We will assess stroke survivors <4-weeks, 3-months, 6-months and 12-months post stroke using a range of neuroimaging and clinical outcome measures. The findings from this study will build the foundations for more personalized health care options for people with severe arm impairment post stroke.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterising Arm Recovery in People With Severe Stroke
Study Start Date : July 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Group/Cohort Intervention/treatment
Longitudinal evaluation of recovery
Stroke survivors with subacute and severe upper limb disability
Other: Longitudinal evaluation of recovery
Stroke survivors will be assessed at four time frames post stroke to evaluate neuroplastic and clinical changes in arm recovery over the first 12-months post stroke.




Primary Outcome Measures :
  1. 3T Magnetic Resonance Imaging (MRI) [ Time Frame: up to 12-months ]
    Determine the structural and functional connectivity of the brain using diffusion weighted imaging, resting state-functional magnetic resonance imaging and myelin water fraction imaging.


Secondary Outcome Measures :
  1. Shoulder abduction and finger extension (SAFE) [ Time Frame: 12-months ]
    Measurement of upper limb strength

  2. Fugl-Meyer Assessment (arm and sensory) [ Time Frame: <4wks, 3-months, 6-months, 12-months ]
    Measurement of upper limb impairment

  3. Motor Assessment Scale items 6,7,8 [ Time Frame: <4wks, 3-months, 6-months, 12-months ]
    Measurement of upper limb activity

  4. REACH (Rating of Everyday Arm Use in the Community and Home) [ Time Frame: <4wks, 3-months, 6-months, 12-months ]
    Self-report measure of everyday arm use

  5. Accelerometry [ Time Frame: <4wks, 3-months, 6-months, 12-months ]
    Measurement of real world arm use (activity count) over a 7-day period at each time frame

  6. PASS (Postural Assessment Scale for Stroke patients) [ Time Frame: <4wks, 3-months, 6-months, 12-months ]
    Measurement of balance (static and dynamic) and lower limb functional tasks

  7. 10-metre walk test [ Time Frame: <4wks, 3-months, 6-months, 12-months ]
    Measurement of walking ability

  8. Montreal Cognitive Assessment (MoCA) [ Time Frame: <4wks, 3-months, 6-months, 12-months ]
    Measurement of cognitive impairment after stroke

  9. Dose of upper limb training [ Time Frame: <4wks, 3-months, 6-months, 12-months ]
    Dose in minutes of passive, active, functional or sensory upper limb tasks performed over a 7-day period at each time frame

  10. National Institute of Stroke Severity Scale [ Time Frame: <4-weeks ]
    Characterise stroke severity

  11. Oxfordshire Bamford Classification [ Time Frame: <4-weeks ]
    Characterise stroke type

  12. Myelin water fraction imaging (WMI) [ Time Frame: <4wks, 3-months, 6-months, 12-months ]
    Determine the myelin content within the brain

  13. Meaningful arm recovery questionnaire [ Time Frame: <4wks, 3-months, 6-months, 12-months ]
    Explore the stroke survivor's perception of meaningful recovery of their upper limb



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Stroke survivors with subacute and severe upper limb disability will be evaluated longitudinally.
Criteria

Inclusion Criteria:

  • adults aged 18 to 90 years;
  • sustained their first stroke;
  • demonstrate subacute (<1 month) and severe upper limb motor deficits (defined by a SAFE [shoulder abduction and finger extension] score of <5 out of 10 points); and
  • can follow single stage commands

Exclusion Criteria:

  • neurological condition other than stroke e.g., Parkinson's disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464085


Contacts
Contact: Kathryn S Hayward, PT PhD 6048273369 kathryn.hayward@ubc.ca
Contact: Lara A Boyd, PT PhD 6048273369 lara.boyd@ubc.ca

Locations
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6T1Z3
Contact: Kathryn S Hayward, PT PhD    6048273369    kathryn.hayward@ubc.ca   
Contact: Lara A Boyd, PT PhD    6048273369    lara.boyd@ubc.ca   
Sub-Investigator: Julie Bernhardt, PT PhD         
Principal Investigator: Lara A Boyd, PT PhD         
Sub-Investigator: Kathryn S Hayward, PT PhD         
Sub-Investigator: Catherine E Lang, PT PhD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Lara A Boyd, PT PhD University of British Columbia

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02464085     History of Changes
Other Study ID Numbers: H15-00083
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of British Columbia:
Stroke
Upper limb
Neuroplastic change
Longitudinal
Function

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases